Methods and apparatuses for injection molding walled structures

ABSTRACT

A process is provided for making a walled structure using an injection molding apparatus. The apparatus has a molding space formed between a mold cavity and an inner core disposed within the mold cavity. The molding space defines a shape of the structure. The process includes injecting molding material into the molding space, moving or retaining a portion of a movable impression member protruding from the inner core within a portion of the molding space so as to create a recess within an inner wall of the structure, and retracting the impression member into the inner core such that the impression member is cleared from the molding space. Precision control in forming the impression member is provided by a closed-loop configuration using a sensor that measures a molding space parameter (e.g., temperature), optionally in combination with a servo drive for activating the impression member.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a U.S. National Phase of International ApplicationNo. PCT/US2016/026122 filed Apr. 6, 2016, which claims priority to U.S.Provisional Patent Application No. 62/145,902 filed Apr. 10, 2015, whichare incorporated herein by reference in their entirety.

FIELD OF INVENTION

The present invention relates to methods and apparatuses for injectionmolding walled structures having one or more openings, such as syringes,cartridges, containers, vials and the like. More particularly, thepresent invention is directed to creating, via injection molding, one ormore recesses in an internal wall of a structure without altering thesurface geometry of the external wall of that structure. Methods andapparatuses according to the invention may be used to create, e.g., adual-chambered medical barrel (e.g., syringe barrel) having a bypassgroove within the inner wall that does not cause the adjacent outer wallto bulge outwardly.

BACKGROUND OF THE INVENTION

As a prelude to describing products and processes according to thepresent invention, some background on the fields of dual-chamberedsyringes and injection molding techniques for medical barrels and othersuch thin-walled tubular structures, is appropriate.

Dual-chambered syringes, such as those described in U.S. Pat. Nos.5,605,542 and 6,817,987, which are incorporated herein by reference intheir entireties, typically include a tubular barrel with an axiallymovable partition disposed within the barrel. The partition separatesand seals off front and rear syringe chambers, one from the other. Thepurpose of these separate chambers is to enable the syringe to hold twoseparate substances, which are generally combined by actuating thesyringe at the time of use. For example, the front chamber may contain alyophilized drug product and the rear chamber may contain a liquidsolvent to be mixed with the drug product at the time of use. Bymaintaining these substances in separate chambers until the time of use,the stability of the preparation may be improved.

When the syringe is actuated at the time of use, the partition movesaxially, towards the front of the syringe (i.e., towards the needle). Inorder to enable fluid communication between front and rear chambers atthe time of use, a dual-chambered syringe typically has a bypass groove(which may also be referred to herein as an impression recess) along aportion of the syringe's inner wall. The bypass groove tends to have alength that exceeds the length of the partition. As such, when thepartition is driven forward and seated over the bypass groove, fluidfrom one chamber is permitted to flow around the partition via thebypass groove into the other chamber, thereby combining the twosubstances that were initially segregated.

As shown in FIG. 1, which is a reproduction of FIG. 1 from U.S. Pat. No.5,605,542, the bypass groove of the syringe (reference numeral 6 in thatfigure) is a recess in the syringe barrel that is formed by a bulging ofthe outer wall of the barrel. Likewise, as shown in FIG. 2, which is areproduction of FIG. 1 from U.S. Pat. No. 6,817,987, the outer wall ofthe syringe barrel adjacent to the bypass groove (reference numeral 9 inthat figure) bulges outwardly. This appears to be typical configurationfor bypass grooves in the dual-chambered syringe art. While thisconfiguration may be suitable for syringes made from glass, there arechallenges associated with producing plastic dual-chambered syringeshaving functional bypasses with good flow properties. These challengesarise from the nature of typical injection molding processes used formaking plastic syringe bodies. To better convey the nature of suchchallenges, a background on the injection molding process, as itpertains to medical barrels (e.g., syringes), is now provided.

FIG. 3 illustrates an exemplary embodiment of a molding assembly formolding a thin-walled plastic tubular structure, e.g., a syringe barrel.An exemplary syringe barrel 12 that may be molded using the moldingassembly is shown in FIGS. 4 and 5.

The molding assembly includes one or more mold cavities 142. The moldcavity 142, shown in detail in FIG. 3, is configured for molding asyringe barrel 12 of the type shown in FIGS. 4 and 5, although it shouldbe understood that the mold cavity 142 may be modified to producesimilar tubular thin-walled structures other than syringe barrels, e.g.,cartridges, parenteral containers, and the like.

The mold cavity 142 is formed as a cylindrical opening 144 in a moldingblock of the assembly. The opening 144 extends in direction D to aninner surface 146 of the molding block. A sleeve 148 may be fittedwithin the molding block and define the opening 144. The sleeve 148 isformed of a material capable of appropriately distributing heat duringmolding and may include a plurality of cooling channels 150.

An inner core 152 fits within the opening 144 to define the interior 20of the syringe barrel 12. The inner core 152 is of a cylindrical shapesimilar to that of the opening 144, but is of a smaller diameter. Amolding space 154 is defined between the opening 144 and the inner core152. The molding space 154 is sized and shaped to form a syringe barrel12, such as that shown in FIGS. 4 and 5. The inner core 152 projectsfrom a core plate, which is located outward in the molding assembly withrespect to the molding block. An injector 156 extends through a portionof the molding block for injecting thermoplastic molding material (e.g.,a cyclic olefin) into the mold cavity 142 during molding.

Upon initiation of a molding operation, a core plate is first moved indirection D, such that the inner core 152 is moved into the opening 144,to create a syringe barrel 12 shaped molding space 154. Molten moldingmaterial is then injected into the mold cavity 142 through the injector156. The molding assembly may be heated before or during this portion ofthe procedure to permit sufficient flow of the molding material to fillthe entire molding space 154. The molding material flows through themolding space 154.

The molding material is then permitted to cool below its melting point,and in some embodiments may be actively cooled by cooling of theassembly, for example by injecting a coolant into cooling channels 150where provided. The core plate is moved outward in direction D,withdrawing the core 152 from the interior 20 of the molded syringebarrel 12. The syringe barrel 12 is withdrawn from the mold cavity 142by being moved outward in direction D, i.e., in a direction along theaxis of the syringe barrel 12.

Injection molding is the most common and preferred method of fabricatingplastic parts because of its speed of production, low labor costs anddesign flexibility. As mentioned above, however, there are challenges toincorporating a standard, outwardly protruding bypass, in a plasticinjection molded syringe barrel. One such challenge is that an outwardprotrusion or bulge from the outer wall of the syringe barrel wouldprevent the syringe from being withdrawn from the mold cavity in adirection along the axis of the syringe barrel. While a mold cavity maybe configured to create a protrusion from the outer wall of the syringe,such a mold would need to be formed from two mold blocks joinedtogether. Once a syringe barrel is formed and cooled, the mold blockswould separate enabling withdrawal of the syringe barrel. This process,however, would imprint a line on the syringe barrel along the seam inwhich the mold blocks had been joined. Syringe bodies often need to betransparent and unblemished to enable visual inspection of the nature ofthe syringe's contents (e.g., to confirm that no particulates aresuspended therein, etc.). A line along the syringe barrel or othervisual blemishes could frustrate this purpose. While withdrawal of thesyringe barrel from a solid one-piece mold cavity in an axial directionavoids the problem of the line blemish, an outward protrusion on aninjection molded syringe barrel prevents withdrawal of the syringebarrel in an axial direction for reasons discussed above.

What is needed, therefore, is a plastic injection molded syringe barrelwith a bypass in the inner wall that does not cause the outer wall tobulge outwardly. More broadly, what is needed are methods andapparatuses for injection molding a walled structure, in which one ormore recesses (including a bypass groove having good flow properties)are impressed into an inner wall of the structure without altering thesurface geometry of the outer wall of the structure.

The foregoing Background of the Invention should be regarded as part ofthe specification of the invention. It is intended that components,elements and aspects of dual chambered syringes, injection moldingapparatuses and processes for injection molding described in theBackground of the Invention may be used as support for aspects of theclaimed invention.

BRIEF SUMMARY OF THE INVENTION

An injection molding apparatus for forming a medical barrel having abypass groove within an inner wall of the medical barrel and anundistorted outer wall such that the medical barrel can be removedaxially (i.e., along a direction of a central axis of the medicalbarrel) from the injection molding apparatus is disclosed. The injectionmolding apparatus comprises: a mold block defining a mold cavity andadapted to receive molten thermoplastic material in the mold cavity;wherein the mold block comprises a unitary piece that is not separableand has a cylindrical opening at one end; an inner core that is adaptedto pass through the cylindrical opening and to occupy a portion withinthe mold cavity to define a molding space that is outside of the innercore but within the mold cavity for forming the medical barrel, andwherein the inner core comprises a longitudinal space therein; anactuator that is axially displaceable within the longitudinal space; andan impression member that cooperates with the actuator to form thebypass groove within the inner wall of the medical barrel when themolding space is filled with molten thermoplastic material.

A dual-chambered medical barrel is disclosed. The dual-chambered medicalbarrel comprises an inner wall and an outer wall, and wherein the innerwall comprises at least one bypass groove having a substantiallyconstant cross section, wherein the outer wall adjacent the bypassgroove has a surface geometry that is unaltered by the bypass groove,and wherein the medical barrel is made from an injection moldablethermoplastic material and wherein the medical barrel is undistorted inshape and transparency following formation of the bypass groove.

A method for forming a medical barrel having a bypass groove within aninner wall of the medical barrel and an undistorted outer wall such thatthe medical barrel can be removed axially from the injection moldingapparatus is disclosed. The method comprises: providing a unitaryunseparable mold block defining a mold cavity and adapted to receivemolten thermoplastic material in the mold cavity and wherein the moldblock comprises a cylindrical opening at one end; inserting an innercore that is adapted to pass through the cylindrical opening and tooccupy a portion within the mold cavity to define a molding space thatis outside of the inner core but within the mold cavity for forming themedical barrel therein and wherein the inner core comprises alongitudinal space therein; positioning an actuator within thelongitudinal space and which is axially displaceable therein; anddisplacing an impression member orthogonally from the actuator to formthe bypass groove within the inner wall of the medical barrel when themolding space is filled with molten thermoplastic material and when theactuator is axially displaced.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic cross sectional view of an embodiment of a syringeillustrated in FIG. 1 of U.S. Pat. No. 5,605,542;

FIG. 2 is an axial section of a dual-chamber syringe illustrated in FIG.1 of U.S. Pat. No. 6,817,987;

FIG. 3 is a cross sectional view of a portion of a molding assembly;

FIG. 4 is a side elevational view of a syringe barrel;

FIG. 5 is a cross sectional view along line 2-2 of FIG. 4;

FIG. 6 is a side elevational view of a syringe barrel according to anaspect of the present invention;

FIG. 7 is a cross sectional view along line A-A of FIG. 6;

FIG. 7A is an enlarged view of a bypass groove in the wall of thesyringe barrel shown in FIG. 7;

FIG. 7B is an enlarged view of the wall of the syringe barrel shown inFIG. 7 illustrating an optional trilayer coating set on the inner wall;

FIG. 7C is an enlarged view of the wall of the syringe barrel shown inFIG. 7 illustrating an optional pH protective coating on the inner wall;

FIG. 8 is an enlarged partial cross sectional view of an injectionmolding apparatus for molding a syringe barrel with an actuator in anextended position;

FIG. 9 is an enlarged partial cross sectional view of the injectionmolding apparatus of FIG. 8 with the actuator in a retracted position;

FIG. 9A is a cross-sectional view of the injection molding apparatus ofthe present invention showing an open-loop configuration for extendingthe actuator;

FIG. 9B is a cross-sectional view of the injection molding apparatus ofthe present invention showing an open-loop configuration for retractingthe actuator;

FIG. 9C is a cross-sectional view of the injection molding apparatus ofthe present invention showing a closed-loop configuration for extendingthe actuator;

FIG. 9D is a cross-sectional view of the injection molding apparatus ofthe present invention showing a closed-loop configuration for retractingthe actuator;

FIG. 9E is an enlarged partial cross-sectional view, indicated in FIG.9C, of a sensor installed in the injection molding apparatus;

FIG. 10 is a cross sectional view of the inner core of the injectionmolding apparatus of FIG. 9;

FIG. 11A is an enlarged cross sectional view of a bypass groove havingsharp outer edges;

FIG. 11B is an enlarged cross sectional view of a bypass groove havingrounded outer edges;

FIG. 12 is a cross sectional view of a portion of the inner core of theinjection molding apparatus of FIGS. 8-10;

FIG. 13 is an enlarged internal perspective view of a portion of theinner core of FIGS. 8-10 and 12;

FIG. 14 is an enlarged perspective view of an opened vial according toan aspect of the present invention;

FIG. 15 is an enlarged perspective view of an injection moldingapparatus for molding the vial of FIG. 14 with an actuator in anextended position; and

FIG. 16 is an enlarged perspective view of the injection moldingapparatus of FIG. 15 with the actuator in a retracted position.

DETAILED DESCRIPTION OF THE INVENTION Bypass Syringe and Process forMolding the Same

In one aspect, the invention is directed to processes and apparatusesfor fabricating medical barrels (sometimes simply referred to herein as“barrels”) through injection molding. As used herein, “medical barrel”refers to a generally tubular vessel adapted for medical use, the vesselhaving at least one opening at an end thereof (and preferably anotheropening at an opposite end). Examples of medical barrels include barrelsfor syringes, pre-filled syringes, cartridges, prefilled cartridges,auto-injectors and other such parenteral packages. While a preferredapplication of the invention, as discussed below, relates to medicalsyringes, it should be understood that the invention is not limited tosyringes, but may include any medical barrel. The invention also broadlyextends to processes and apparatuses used for injection moldingundercuts or impressions on the inner walls of other types of containers(e.g. vials).

Referring now to FIGS. 6-7A, there is shown an exemplary syringe barrel212 according to an aspect of the present invention. The syringe barrel212 is formed as a generally tubular wall 216 with an opened first end218 leading to an interior 220. Along a portion of the inner wall 216 aof the syringe barrel 212 is a recessed longitudinal bypass groove 217.Notably, unlike typical dual-chambered syringe configurations,particularly those made from glass, the outer wall 216 b adjacent to thebypass groove 217 does not bulge outwardly, thus leaving that section ofthe outer wall 216 b unaltered. In other words, the bypass groove 217does not alter the surface geometry of the outer wall 216 b adjacent tothe bypass groove 217. In use, plungers and a sealing partition may beslidably housed within the interior 220 of the syringe barrel 212 tocreate a dual-chambered syringe, wherein the initial position of thepartition would be between the first end 218 and the bypass groove 217.Such a configuration would enable a syringe made from the syringe barrel212 to contain two separate substances that could be combined at thetime of use, as described above regarding dual-chambered syringes. Aneedle receiving hub 224 protrudes from the second end 222 of the barrel212, outward from an outward convexly curved end wall 230. In use, aneedle may extend through the hub 224 from the exterior to the interior220 of the hub 224, for transmitting an injectable material out from thesyringe and into a patient.

The syringe barrel 212 is preferably fabricated from one or morethermoplastic materials that appear clear and glass-like in final form.Such materials include, for example cyclic olefin polymers (COP), cyclicolefin copolymers (COC) and polycarbonate. While it is preferable thatthe barrel material be clear in appearance for certain applications, theinvention is not limited to clear plastics, but may include otherpolymers, for example, PET, polystyrene and polypropylene.

An advantage of the bypass grove 217 being housed entirely within theinner wall 216 a of the syringe barrel 212 (i.e., without bulgingoutward from the outer wall 216 b) is that the final syringe retains thetubular appearance and outer profile of a standard (i.e.,non-dual-chambered) syringe. An additional advantage relates to themanner in which the syringe barrel 212 may be fabricated, discussed now.

To fabricate the syringe barrel 212 by injection molding, the equipmentand process steps are similar in many respects to those used to createthe syringe barrel 12 shown in FIGS. 4 and 5, which may be molded usingthe molding assembly shown in FIG. 3. However, to create an internalrecess such as the bypass grove 217, which does not bulge outwardly fromthe outer wall 216 b of the syringe barrel 212, a retractable structure(e.g. an impression member) may be provided from within the inner coreof the molding assembly to create an impression or recess within theinner wall 216 a.

For example, referring to FIGS. 8 and 9, there is shown an injectionmolding apparatus 300 for molding a thin-walled tubular structure (e.g.,a syringe barrel 212) having an impression or recess within the innerwall of the structure, such as a bypass groove 217. The apparatus 300,which may be integrated into, e.g., the molding assembly described aboveand shown in FIG. 3, includes a mold cavity 342 adapted to receivemolten thermoplastic material for forming a syringe barrel 212. The moldcavity 342 is optionally constructed of a solid one-piece mold block asopposed to being formed from joining together two separate mold blocks.This feature would enable the syringe barrel 212 to be axially withdrawn(i.e., in a direction along a central axis of the barrel 212) once it iscomplete, without separating the mold blocks. In this way, one may avoidimprinting a line on the syringe barrel along the seam in which the moldblocks had been joined, as discussed above.

The mold cavity 342 is formed from a cylindrical opening 344 of amolding block of the molding assembly. An inner core 352, of which across sectional view is shown in FIG. 10, fits within the opening todefine the interior 220 of the syringe barrel 212. The inner core 352 isof a cylindrical shape similar to that of the opening 344, but is of asmaller diameter. A molding space 354 is defined between the opening 344and the inner core 352. The molding space 354 is sized and shaped toform a syringe barrel 212, such as that shown in FIGS. 6-7A. Tofabricate the syringe barrel 212, melted thermoplastic material isinjected into the molding space 354.

Within the inner core 352 is a longitudinal space 380. An actuator 382is disposed within the space 380 and is axially movable (i.e., in adirection along a central axis of the space 380) within the space 380.The actuator 382, which can be driven, e.g., pneumatically, electricallyor hydraulically, may be slidable from an extended position within thespace 380, as shown in FIG. 8, to a retracted position, as shown in FIG.9. The actuator 382 may include a slot portion 384 having an impressionmember 386 disposed therein. A portion of the impression member 386 isslidably disposed within a track 388 which runs axially along a portionof the actuator 382 at a slight incline. The slot portion 384 furtherincludes a ramp 390, the majority of which comprises an inclinesubstantially parallel to the track 388.

In use, when the actuator 382 is in an extended position, as shown inFIG. 8, the impression member 386 is seated on a raised section of theramp 390. In this position, the impression member 386 protrudes slightlythrough a window 392 in the inner core 352 and presses into the moltenplastic in the molding space 354 to form a recess in the inner wall 216a of the syringe barrel 212. This recess constitutes the internal bypassgroove 217, e.g., as shown in FIGS. 6-7A, in the completed syringebarrel 212. In a preferred embodiment, the impression member 386 movesperpendicular to the axial direction of movement of the actuator 382. Inother words, movement of the impression member 386 perpendicular to theaxial direction of movement of the actuator 382 and/or perpendicular tothe central axis of the inner core 352, is driven by axial movement ofthe actuator 382. In this way, the bypass groove 217 is perpendicular,as opposed, e.g., to oblique, to the center axis of the syringe barrel212. This enables the creation of a bypass groove 217 having asubstantially constant cross section—a feature which the inventorssubmit would not be attainable were the impression member 386 to move ina direction that is not perpendicular (e.g., oblique) to the axialdirection of movement of the actuator 382. This feature may allow forbetter control of the shape of the bypass groove 217 for improved fluidflow through the bypass groove 217, when used to mix components of adual chambered syringe.

As discussed above, this bypass groove 217 is located entirely withinthe inner wall 216 a and does not bulge outwardly from the outer wall216 b. When the actuator 382 is in its retracted position, as shown inFIG. 9, the impression member 386 is seated on a lowered section of theramp 390. In this position, the impression member 386 is withdrawn fromthe molten plastic and its profile is contained entirely within theinner core 352. Thus, in one aspect, the present invention is directedto an impression member 386 which is movable from an extended positionwherein a portion of the impression member 386 protrudes into themolding space 354, to a retracted position wherein the impression member386 is cleared from the molding space 354 and optionally housed entirelywithin the inner core 352. Again, the impression member 386 may movefrom the extended position to the retracted position in a directionperpendicular to the axial direction of movement of the actuator 382and/or perpendicular to the central axis of the inner core 352. Sincethe impression member 386, as shown in FIG. 9, does not interfere withthe material in the molding space 354, when the syringe barrel 212 issufficiently cool and thus in solid form, the syringe barrel 212 may bewithdrawn from the molding apparatus 300 in an axial direction.

Thus, the molding apparatus 300 may be used to create a syringe barrel212 in a process comprising the following steps: injecting moltenthermoplastic molding material into a syringe barrel-shaped moldingspace; retaining a predetermined portion of the impression member withinthe molding space so that the molding material forms around the portionof the impression member thereby creating a recess within a wall of thecompleted syringe barrel; and, after the molding material has beencooled to a sufficiently solid state, withdrawing the impression memberfrom the recess, optionally in a direction perpendicular to the axialdirection of movement of the actuator and/or perpendicular to thecentral axis of the inner core, to enable withdrawal of the completedsyringe from the molding apparatus in an axial direction. Referring toFIG. 11A, it is contemplated that this process would result in a bypassgroove 217 having sharp outer corners 219 a.

As an alternative, the molding apparatus 300 may be used to create asyringe barrel 212 in a process comprising the following steps:injecting molten thermoplastic molding material into a syringebarrel-shaped molding space; moving a predetermined portion of theimpression member into the molding space to displace some of the moldingmaterial and thus create a recess within a wall of the completed syringebarrel; and, after the molding material has been cooled to asufficiently solid state, withdrawing the impression member from therecess, optionally in a direction perpendicular the axial direction ofmovement of the actuator and/or perpendicular to the central axis of theinner core, to enable withdrawal of the completed syringe from themolding space in an axial direction. In one variation of thisalternative, the molding space is substantially filled (e.g., 98%) withmolding material and the impression member's creation of the recessdisplaces the molding material sufficiently to completely fill themolding space. In another variation of this alternative, the moldingspace is substantially filled (e.g., 95% to 99.5% by volume, optionallyabout 97%, optionally about 98%, optionally about 99%) with moldingmaterial, the impression member creates the recess, and additionalmolding material is injected to completely fill the molding space.Referring to FIG. 11B, it is contemplated that any variations of thisalternative process would result in a bypass groove 217 having roundedouter corners 219 b.

As mentioned previously, the actuator 382 can be driven, e.g.,pneumatically, electrically or hydraulically. Where actuator 382 controlis hydraulic or pneumatic (H/P), by way of example only, the H/P drive400 operates in an open-loop mode whereby a drive ram 402 extends orretracts the actuator 382 based on time criteria, actuator extensionindicated by the arrow 403 and actuator retraction indicated by thearrow 404. In particular, the H/P drive 400 (e.g., the HMR-02 or X 20motor by Linde, or TR Pneumatic Drive Motor 126758-8 by Honeywell)activates the actuator 382 after a predetermined time once the moldingspace 354 is substantially filled (e.g., 95%-99.5%, optionally 97%,optionally 98%, optionally 99%). By way of example only, thepredetermined time may comprise 0.55 seconds following mold closingafter which the H/P drive 400 is activated to extend the actuator 382(FIG. 9A) and then retract it (FIG. 9B), thereby forming the bypassgroove 217.

Alternatively, a more preferred actuator control is a closed-loopconfiguration as shown in FIGS. 9C-9E. In particular, a sensor 500(e.g., a pressure sensor, a temperature sensor, etc.) is positionedwithin the mold body, beyond projected site where the bypass groove 217is to be formed, as shown in FIGS. 9C/9D. The sensor 500 provides sensordata to a motor or other means that actuates or drives the actuator,e.g., a servo drive 502 (e.g., a servo motor, step motor, etc.). In anexemplary embodiment, if the sensor 500 detects a particular sensorthreshold (e.g., pressure of mold, temperature of mold, etc.), the servodrive 502 (e.g., NT Motor by Emerson Industrial Automation, OMHT seriesstepper motor by Omega, etc.) extends the actuator 382 (FIG. 9C) usingthe drive ram 402 and then retracts the actuator 382 (FIG. 9D) via thedrive ram 402 to form the optimum bypass groove 217 with minimizeddistortions in the medical barrel. Thus, this closed-loop configurationprovides a precise mechanism for forming the bypass groove 217.Furthermore, as shown most clearly in FIG. 9E, to avoid introducing anydistortions in the molding space 354 by the presence of the sensor 500itself, the sensor head 500A is not in direct contact with the medicalbarrel material; rather, a thin membrane 504 (e.g., comprising steel),forming a “blind hole” is positioned between the sensor head 502A andmolding space 354. As such, the sensor 500 is able to detect therespective parameter of the mold space 354 without introducing anydistortions in the medical barrel body. The end result of thisclosed-loop actuator control is the formation of a medical barrel thatis undistorted in shape and transparency following formation of thebypass groove 217.

Whatever type of sensor (e.g., pressure, temperature, flow sensor, etc.)is used for the sensor 500, the key is that the monitored mold cavityparameter is meant to correspond to a sufficient volume of resin in themold that has been achieved (e.g., e.g., 95%-99.5%, optionally 97%,optionally 98%, optionally 99%). By way of example only, where thesensor 500 comprises a pressure sensor (e.g., Kistler Type 6183B-cavitypressure sensor), a pressure level of 550-600 bars detected by thesensor 500 will cause the servo drive 502 to operate the actuator 382 asdescribed above to form the optimum bypass groove 217. Where temperaturesensors are to be used, an industrial temperature sensor (e.g., the hightemperature inductive sensor IN5-18TNSext by Locon Sensor) can be usedto detect the temperature range corresponding to the substantial moldfill volume (e.g., 95%-99.5%, optionally 97%, optionally 98%, optionally99%). Alternatively, an industrial non-contact flow sensor (e.g., theFLO-DAR AV flow sensor by the Hach Company) can be used to detect theflow of mold that corresponds to the substantial mold fill volume (e.g.,95%-99.5%, optionally 97%, optionally 98%, optionally 99%) which thentriggers the servo drive 500 to extend/retract the drive ram 402 to formthe optimum bypass groove 217.

A skilled artisan would understand that other alternative process stepsmay also be used according to the spirit and scope of the presentinvention. Notably, whichever way the process is specifically carriedout, the end result is preferably a thermoplastic (e.g., COC or COP)syringe barrel 212 without a line down its center because the barrel isformed from a solid one-piece mold and is withdrawn from the mold cavityin an axial direction.

In order to regulate temperature of the molding material during themolding process, a plurality of cooling channels 394, shown in FIGS. 12and 13, optionally run axially within the inner core 352. The coolingchannels 394 are adjacent to the space 380 within the inner core 352 onone side and the molding space 354 on the other. The cooling channels394 are optionally adapted to facilitate the flow of coolant, whichabsorbs heat from the molding material. The cooling channels 394 mayempty into an optionally toroid or torus shaped hollow 396 at a far endof the inner core 352. This configuration permits continuous flow of thecoolant through the inner core 352.

Barrier, pH Protective and Trilayer Coatings for Syringes

In another aspect, the invention includes use of syringes having a PECVDcoating or PECVD coating set. This aspect of the invention will bediscussed primarily in the context of a pre-filled syringe, particularlya dual-chambered syringe, as a preferred implementation of optionalaspects of the invention. Again, however, it should be understood thatthe present invention may include any parenteral container having abypass groove and that utilizes a plunger, partition and bypass in theinner wall, such as dual-chambered syringes, cartridges, auto-injectors,pre-filled syringes, pre-filled cartridges or vials.

For some applications, it may be desired to provide one or more coatingsor layers to the interior wall of a parenteral container to modify theproperties of that container. For example, one or more coatings orlayers may be added to a parenteral container, e.g., to improve thebarrier properties of the container and prevent interaction between thecontainer wall (or an underlying coating) and drug product held withinthe container. It is contemplated that these coatings provide aparenteral package having the beneficial properties of both plastic andglass, without typical drawbacks possessed by each such material alone.This is a particularly unique concept and application in the field ofdual chambered syringes.

For example, as shown in FIG. 7B, which is a first alternativeembodiment of an enlarged section view of the syringe barrel 212 of FIG.7, the inner wall 216 a of the syringe barrel 212 may include a coatingset 700 comprising one or more coatings or layers. The barrel 212 mayinclude at least one tie coating or layer 702, at least one barriercoating or layer 704, and at least one organo-siloxane coating or layer706. The organo-siloxane coating or layer 706 preferably has pHprotective properties. This embodiment of the coating set 700 isreferred to herein as a “trilayer coating” in which the barrier coatingor layer 704 of SiO), is protected against contents having a pHotherwise high enough to remove it by being sandwiched between the pHprotective organo-siloxane coating or layer 706 and the tie coating orlayer 702. The contemplated thicknesses of the respective layers in nm(preferred ranges in parentheses) are given in the following TrilayerThickness Table:

Trilayer Thickness Table Adhesion Barrier Protection  5-100  20-200 50-500 (5-20) (20-30) (100-200)

Properties and compositions of each of the coatings that make up thetrilayer coating are now described.

The tie coating or layer 702 has at least two functions. One function ofthe tie coating or layer 702 is to improve adhesion of a barrier coatingor layer 704 to a substrate (e.g., the inner wall 216 a of the barrel212), in particular a thermoplastic substrate, although a tie layer canbe used to improve adhesion to a glass substrate or to another coatingor layer. For example, a tie coating or layer, also referred to as anadhesion layer or coating can be applied to the substrate and thebarrier layer can be applied to the adhesion layer to improve adhesionof the barrier layer or coating to the substrate.

Another function of the tie coating or layer 702 is that when appliedunder a barrier coating or layer 704, the tie coating or layer 702 canimprove the function of a pH protective organo-siloxane coating or layer706 applied over the barrier coating or layer 704.

The tie coating or layer 702 can be composed of, comprise, or consistessentially of SiO_(x)C_(y), in which x is between 0.5 and 2.4 and y isbetween 0.6 and 3. Alternatively, the atomic ratio can be expressed asthe formula Si_(w)O_(x)C_(y). The atomic ratios of Si, O, and C in thetie coating or layer 289 are, as several options:

Si 100:O 50-150:C 90-200 (i.e. w=1, x=0.5 to 1.5, y=0.9 to 2);

Si 100:O 70-130:C 90-200 (i.e. w=1, x=0.7 to 1.3, y=0.9 to 2)

Si 100:O 80-120:C 90-150 (i.e. w=1, x=0.8 to 1.2, y=0.9 to 1.5)

Si 100:O 90-120:C 90-140 (i.e. w=1, x=0.9 to 1.2, y=0.9 to 1.4), or

Si 100:O 92-107:C 116-133 (i.e. w=1, x=0.92 to 1.07, y=1.16 to 1.33).

The atomic ratio can be determined by XPS. Taking into account the Hatoms, which are not measured by XPS, the tie coating or layer 702 maythus in one aspect have the formula Si_(w)O_(x)C_(y)H_(z) (or itsequivalent S_(i)O_(x)C_(y)), for example where w is 1, x is from about0.5 to about 2.4, y is from about 0.6 to about 3, and z is from about 2to about 9. Typically, a tie coating or layer 702 would hence contain36% to 41% carbon normalized to 100% carbon plus oxygen plus silicon.

The barrier coating or layer for any embodiment defined in thisspecification (unless otherwise specified in a particular instance) is acoating or layer, optionally applied by PECVD as indicated in U.S. Pat.No. 7,985,188. The barrier coating preferably is characterized as an“SiO_(x)” coating, and contains silicon, oxygen, and optionally otherelements, in which x, the ratio of oxygen to silicon atoms, is fromabout 1.5 to about 2.9. The thickness of the SiO_(x) or other barriercoating or layer can be measured, for example, by transmission electronmicroscopy (TEM), and its composition can be measured by X-rayphotoelectron spectroscopy (XPS). The barrier layer is effective toprevent oxygen, carbon dioxide, or other gases from entering thecontainer and/or to prevent leaching of the pharmaceutical material intoor through the container wall.

Referring again to FIG. 7B, the barrier coating or layer 704 of SiO_(x),in which x is between 1.5 and 2.9, may be applied by plasma enhancedchemical vapor deposition (PECVD) directly or indirectly to thethermoplastic inner wall 216 a of the barrel 212 (in this example, a tiecoating or layer 702 is interposed between them) so that in the filledsyringe barrel 212, the barrier coating or layer 704 is located betweenthe inner or interior surface of the inner wall 216 a of the barrel 212and the injectable medicine contained within the barrel 212.

Certain barrier coatings or layers 704 such as SiOx as defined here havebeen found to have the characteristic of being subject to beingmeasurably diminished in barrier improvement factor in less than sixmonths as a result of attack by certain relatively high pH contents ofthe coated vessel as described elsewhere in this specification,particularly where the barrier coating or layer directly contacts thecontents. This issue can be addressed using an organo-siloxane coatingor layer as discussed in this specification.

Preferred methods of applying the barrier layer and tie layer to theinner surface of the barrel 212 is by plasma enhanced chemical vapordeposition (PECVD), such as described in, e.g., U.S. Pat. App. Pub. No.20130291632.

The Applicant has found that barrier layers or coatings of SiO_(x) areeroded or dissolved by some fluids, for example aqueous compositionshaving a pH above about 5. Since coatings applied by chemical vapordeposition can be very thin—tens to hundreds of nanometers thick—even arelatively slow rate of erosion can remove or reduce the effectivenessof the barrier layer in less time than the desired shelf life of aproduct package. This is particularly a problem for fluid pharmaceuticalcompositions, since many of them have a pH of roughly 7, or more broadlyin the range of 5 to 9, similar to the pH of blood and other human oranimal fluids. The higher the pH of the pharmaceutical preparation, themore quickly it erodes or dissolves the SiO_(x) coating. Optionally,this problem can be addressed by protecting the barrier coating or layer704, or other pH sensitive material, with a pH protectiveorgano-siloxane coating or layer 706.

Optionally, the pH protective organo-siloxane coating or layer 706 canbe composed of, comprise, or consist essentially ofSi_(w)O_(x)C_(y)H_(z) (or its equivalent SiO_(x)C_(y)) orSi_(w)N_(x)C_(y)H_(z) or its equivalent SiN_(x)C_(y)). The atomic ratioof Si:O:C or Si:N:C can be determined by XPS (X-ray photoelectronspectroscopy). Taking into account the H atoms, the pH protectivecoating or layer may thus in one aspect have the formulaSi_(w)O_(x)C_(y)H_(z), or its equivalent SiO_(x)C_(y), for example wherew is 1, x is from about 0.5 to about 2.4, y is from about 0.6 to about3, and z is from about 2 to about 9.

Typically, expressed as the formula Si_(w)O_(x)C_(y), the atomic ratiosof Si, O, and C are, as several options:

Si 100:O 50-150:C 90-200 (i.e. w=1, x=0.5 to 1.5, y=0.9 to 2);

Si 100:O 70-130:C 90-200 (i.e. w=1, x=0.7 to 1.3, y=0.9 to 2)

Si 100:O 80-120:C 90-150 (i.e. w=1, x=0.8 to 1.2, y=0.9 to 1.5)

Si 100:O 90-120:C 90-140 (i.e. w=1, x=0.9 to 1.2, y=0.9 to 1.4)

Si 100:O 92-107:C 116-133 (i.e. w=1, x=0.92 to 1.07, y=1.16 to 1.33), or

Si 100:O 80-130:C 90-150.

Alternatively, the organo-siloxane coating or layer can have atomicconcentrations normalized to 100% carbon, oxygen, and silicon, asdetermined by X-ray photoelectron spectroscopy (XPS) of less than 50%carbon and more than 25% silicon. Alternatively, the atomicconcentrations are from 25 to 45% carbon, 25 to 65% silicon, and 10 to35% oxygen. Alternatively, the atomic concentrations are from 30 to 40%carbon, 32 to 52% silicon, and 20 to 27% oxygen. Alternatively, theatomic concentrations are from 33 to 37% carbon, 37 to 47% silicon, and22 to 26% oxygen.

Optionally, the atomic concentration of carbon in the pH protectivecoating or layer 706, normalized to 100% of carbon, oxygen, and silicon,as determined by X-ray photoelectron spectroscopy (XPS), can be greaterthan the atomic concentration of carbon in the atomic formula for theorganosilicon precursor. For example, embodiments are contemplated inwhich the atomic concentration of carbon increases by from 1 to 80atomic percent, alternatively from 10 to 70 atomic percent,alternatively from 20 to 60 atomic percent, alternatively from 30 to 50atomic percent, alternatively from 35 to 45 atomic percent,alternatively from 37 to 41 atomic percent.

Optionally, the atomic ratio of carbon to oxygen in the pH protectivecoating or layer 706 can be increased in comparison to the organosiliconprecursor, and/or the atomic ratio of oxygen to silicon can be decreasedin comparison to the organosilicon precursor.

An exemplary empirical composition for a pH protective coating accordingto the present invention is SiO_(1.3)C_(0.8)H_(3.6).

Optionally in any embodiment, the pH protective coating or layer 706comprises, consists essentially of, or consists of PECVD applied siliconcarbide.

Optionally in any embodiment, the pH protective coating or layer 706 isapplied by employing a precursor comprising, consisting essentially of,or consisting of a silane. Optionally in any embodiment, the silaneprecursor comprises, consists essentially of, or consists of any one ormore of an acyclic or cyclic silane, optionally comprising, consistingessentially of, or consisting of any one or more of silane,trimethylsilane, tetramethylsilane, Si2-Si4 silanes, triethyl silane,tetraethyl silane, tetrapropylsilane, tetrabutylsilane, oroctamethylcyclotetrasilane, or tetramethylcyclotetrasilane.

Optionally in any embodiment, the pH protective coating or layer 706comprises, consists essentially of, or consists of PECVD appliedamorphous or diamond-like carbon. Optionally in any embodiment, theamorphous or diamond-like carbon is applied using a hydrocarbonprecursor. Optionally in any embodiment, the hydrocarbon precursorcomprises, consists essentially of, or consists of a linear, branched,or cyclic alkane, alkene, alkadiene, or alkyne that is saturated orunsaturated, for example acetylene, methane, ethane, ethylene, propane,propylene, n-butane, i-butane, butane, propyne, butyne, cyclopropane,cyclobutane, cyclohexane, cyclohexene, cyclopentadiene, or a combinationof two or more of these. Optionally in any embodiment, the amorphous ordiamond-like carbon coating has a hydrogen atomic percent of from 0.1%to 40%, alternatively from 0.5% to 10%, alternatively from 1% to 2%,alternatively from 1.1 to 1.8%.

Optionally in any embodiment, the pH protective coating or layer 706comprises, consists essentially of, or consists of PECVD applied SiNb.Optionally in any embodiment, the PECVD applied SiNb is applied using asilane and a nitrogen-containing compound as precursors. Optionally inany embodiment, the silane is an acyclic or cyclic silane, optionallycomprising, consisting essentially of, or consisting of silane,trimethylsilane, tetramethylsilane, Si2-Si4 silanes, triethylsilane,tetraethylsilane, tetrapropylsilane, tetrabutylsilane,octamethylcyclotetrasilane, or a combination of two or more of these.Optionally in any embodiment, the nitrogen-containing compoundcomprises, consists essentially of, or consists of any one or more of:nitrogen gas, nitrous oxide, ammonia or a silazane. Optionally in anyembodiment, the silazane comprises, consists essentially of, or consistsof a linear silazane, for example hexamethylene disilazane (HMDZ), amonocyclic silazane, a polycyclic silazane, a polysilsesquiazane, or acombination of two or more of these.

Optionally in any embodiment, the PECVD for the pH protective coating orlayer 706 is carried out in the substantial absence or complete absenceof an oxidizing gas. Optionally in any embodiment, the PECVD for the pHprotective coating or layer 706 is carried out in the substantialabsence or complete absence of a carrier gas.

Optionally an FTIR absorbance spectrum of the pH protective coating orlayer 706 SiOxCyHz has a ratio greater than 0.75 between the maximumamplitude of the Si—O—Si symmetrical stretch peak normally locatedbetween about 1000 and 1040 cm-1, and the maximum amplitude of theSi—O—Si asymmetric stretch peak normally located between about 1060 andabout 1100 cm-1. Alternatively in any embodiment, this ratio can be atleast 0.8, or at least 0.9, or at least 1.0, or at least 1.1, or atleast 1.2. Alternatively in any embodiment, this ratio can be at most1.7, or at most 1.6, or at most 1.5, or at most 1.4, or at most 1.3. Anyminimum ratio stated here can be combined with any maximum ratio statedhere, as an alternative embodiment.

Optionally, in any embodiment the pH protective coating or layer 706, inthe absence of the medicament, has a non-oily appearance. Thisappearance has been observed in some instances to distinguish aneffective pH protective coating or layer 706 from a lubricity layer(e.g., as described in U.S. Pat. No. 7,985,188), which in some instanceshas been observed to have an oily (i.e. shiny) appearance.

The pH protective coating or layer 706 optionally can be applied byplasma enhanced chemical vapor deposition (PECVD) of a precursor feedcomprising an acyclic siloxane, a monocyclic siloxane, a polycyclicsiloxane, a polysilsesquioxane, a monocyclic silazane, a polycyclicsilazane, a polysilsesquiazane, a silatrane, a silquasilatrane, asilproatrane, an azasilatrane, an azasilquasiatrane, an azasilproatrane,or a combination of any two or more of these precursors. Someparticular, non-limiting precursors contemplated for such use includeoctamethylcyclotetrasiloxane (OMCTS).

Optionally, an FTIR absorbance spectrum of the pH protective coating orlayer 706 of composition SiOxCyHz has a ratio greater than 0.75 betweenthe maximum amplitude of the Si—O—Si symmetrical stretch peak betweenabout 1000 and 1040 cm-1, and the maximum amplitude of the Si—O—Siasymmetric stretch peak between about 1060 and about 1100 cm-1.

Other precursors and methods can be used to apply the pH protectivecoating or layer 706 or passivating treatment. For example,hexamethylene disilazane (HMDZ) can be used as the precursor. HMDZ hasthe advantage of containing no oxygen in its molecular structure. Thispassivation treatment is contemplated to be a surface treatment of theSiOx barrier layer with HMDZ. To slow down and/or eliminate thedecomposition of the silicon dioxide coatings at silanol bonding sites,the coating must be passivated. It is contemplated that passivation ofthe surface with HMDZ (and optionally application of a few mono layersof the HMDZ-derived coating) will result in a toughening of the surfaceagainst dissolution, resulting in reduced decomposition. It iscontemplated that HMDZ will react with the —OH sites that are present inthe silicon dioxide coating, resulting in the evolution of NH3 andbonding of S—(CH3)3 to the silicon (it is contemplated that hydrogenatoms will be evolved and bond with nitrogen from the HMDZ to produceNH3).

Another way of applying the pH protective coating or layer 706 is toapply as the pH protective coating or layer 706 an amorphous carbon orfluorocarbon coating, or a combination of the two.

Amorphous carbon coatings can be formed by PECVD using a saturatedhydrocarbon, (e.g. methane or propane) or an unsaturated hydrocarbon(e.g. ethylene, acetylene) as a precursor for plasma polymerization.Fluorocarbon coatings can be derived from fluorocarbons (for example,hexafluoroethylene or tetrafluoroethylene). Either type of coating, or acombination of both, can be deposited by vacuum PECVD or atmosphericpressure PECVD. It is contemplated that that an amorphous carbon and/orfluorocarbon coating will provide better passivation of an SiOx barrierlayer than a siloxane coating since an amorphous carbon and/orfluorocarbon coating will not contain silanol bonds.

It is further contemplated that fluorosilicon precursors can be used toprovide a pH protective coating or layer 706 over an SiOx barrier layer.This can be carried out by using as a precursor a fluorinated silaneprecursor such as hexafluorosilane and a PECVD process. The resultingcoating would also be expected to be a non-wetting coating.

Yet another coating modality contemplated for protecting or passivatingan SiOx barrier layer is coating the barrier layer using apolyamidoamine epichlorohydrin resin. For example, the barrier coatedpart can be dip coated in a fluid polyamidoamine epichlorohydrin resinmelt, solution or dispersion and cured by autoclaving or other heatingat a temperature between 60 and 100° C. It is contemplated that acoating of polyamidoamine epichlorohydrin resin can be preferentiallyused in aqueous environments between pH 5-8, as such resins are known toprovide high wet strength in paper in that pH range. Wet strength is theability to maintain mechanical strength of paper subjected to completewater soaking for extended periods of time, so it is contemplated that acoating of polyamidoamine epichlorohydrin resin on an SiOx barrier layerwill have similar resistance to dissolution in aqueous media. It is alsocontemplated that, because polyamidoamine epichlorohydrin resin impartsa lubricity improvement to paper, it will also provide lubricity in theform of a coating on a thermoplastic surface made of, for example, COCor COP.

Even another approach for protecting an SiOx layer is to apply as a pHprotective coating or layer 706 a liquid-applied coating of apolyfluoroalkyl ether, followed by atmospheric plasma curing the pHprotective coating or layer 706. For example, it is contemplated thatthe process practiced under the trademark TriboGlide® can be used toprovide a pH protective coating or layer 706 that is also provideslubricity.

Thus, a pH protective coating for a thermoplastic syringe wall accordingto an aspect of the invention may comprise, consist essentially of, orconsist of any one of the following: plasma enhanced chemical vapordeposition (PECVD) applied silicon carbide having the formula SiOxCyHz,in which x is from 0 to 0.5, alternatively from 0 to 0.49, alternativelyfrom 0 to 0.25 as measured by X ray photoelectron spectroscopy (XPS), yis from about 0.5 to about 1.5, alternatively from about 0.8 to about1.2, alternatively about 1, as measured by XPS, and z is from 0 to 2 asmeasured by Rutherford Backscattering Spectrometry (RBS), alternativelyby Hydrogen Forward Scattering Spectrometry (HFS); or PECVD appliedamorphous or diamond-like carbon, CHz, in which z is from 0 to 0.7,alternatively from 0.005 to 0.1, alternatively from 0.01 to 0.02; orPECVD applied SiNb, in which b is from about 0.5 to about 2.1,alternatively from about 0.9 to about 1.6, alternatively from about 1.2to about 1.4, as measured by XPS.

Referring now to FIG. 7C, there is shown a second alternative embodimentof an enlarged section view of the syringe barrel 212 of FIG. 7. Asshown in FIG. 7C, the syringe barrel 212 may include a organo-siloxanecoating or layer 706 disposed directly on the inner wall 216 a of thesyringe barrel 212, rather than, e.g., as a top layer of a coating set.Optionally, the organo-siloxane coating or layer 706 has pH protectiveproperties. Thus, optionally, the invention may involve use of aorgano-siloxane coating or layer as a plunger-contacting and partitioncontacting surface, whether the organo-siloxane coating or layer is thetop-most layer of a coating set or is by itself disposed directly ontothe barrel wall.

PECVD apparatus suitable for applying any of the PECVD coatings orlayers described in this specification, including the tie coating orlayer 702, the barrier coating or layer 704 or the organo-siloxanecoating or layer 706, is shown and described in U.S. Pat. No. 7,985,188and U.S. Pat. App. Pub. No. 20130291632, both of which are incorporatedherein by reference in their entireties. This apparatus optionallyincludes a vessel holder, an inner electrode, an outer electrode, and apower supply. A vessel seated on the vessel holder defines a plasmareaction chamber, optionally serving as its own vacuum chamber.Optionally, a source of vacuum, a reactant gas source, a gas feed or acombination of two or more of these can be supplied. Optionally, a gasdrain, not necessarily including a source of vacuum, is provided totransfer gas to or from the interior of a vessel seated on the port todefine a closed chamber.

Processes for Injection Molding Alternative Walled Structures

In an optional aspect, the present invention is not limited to syringes,cartridges and other similar tubular thin-walled structures. Processesand molding assemblies according to the present invention may be broadlyused to create an impression or recess in the internal wall of anyinjection molded product having an opening in at least one end, e.g.,containers, vials, test-tubes, ampules, pipes, cups, etc. For example,there is shown in FIG. 14 a plastic vial 412, according to the presentinvention, having a small recess 417 in the internal wall 416 a thereof.The recess 417 may be used, for example, to receive and retain a secondpart, e.g., a dispensing orifice for controlled flow of the vial'scontents.

The vial 412 may be injection molded by implementing similar techniquesand components used to fabricate the syringe barrel 212, as discussedabove. Referring to FIGS. 15 and 16, there is shown the end portion ofan injection molding apparatus 400 for molding the vial 412. Theapparatus 400, which may be integrated into, e.g., a molding assemblysimilar to that used for making the syringe barrel 212, includes a moldcavity 442 adapted to receive molten thermoplastic material for formingthe vial 412. The mold cavity 442 is preferably constructed of a solidone-piece mold block as opposed to being formed from joining togethertwo separate mold blocks. This preferred feature would enable the vial412 to be withdrawn axially once it is complete.

The mold cavity 442 is formed from a vial-shaped opening 444 of amolding block of the molding assembly. An inner core 452 fits within theopening 444 to define the interior 420 of the vial 412. The inner core452 is vial-shaped, substantially like the opening 444, but has slightlysmaller dimensions. A molding space 454 is defined between the opening444 and the inner core 452. The molding space 454 is sized and shaped toform the vial 412. To fabricate the vial 412, melted thermoplasticmaterial is injected into the molding space 454.

Within the inner core is a space 480 having a generally rectangularcuboid actuator 482 disposed therein, the actuator 482 being axiallymovable within the space 480. The actuator 482 may be slidable from anextended position within the space 480, as shown in FIG. 15, to aretracted position, as shown in FIG. 16. The actuator 482 may include aslot portion 484 having an impression member 486 slidably disposedtherein. The slot portion 484 includes a ramp 488. In use, when theactuator 482 is in its extended position, as shown in FIG. 15, theimpression member 486 is seated on a raised section of the ramp 488. Inthis position, the impression member 486 protrudes slightly through awindow 490 in the inner core 452 and presses into the molten plastic inthe molding space 454 to form an impression in the inner wall 416 a ofthe vial 412. This impression constitutes the recess 417, e.g., as shownin FIG. 14, in the completed vial 412. This recess 417 is preferablylocated entirely within the inner wall 416 a of the vial and does notbulge outward from the outer wall 416 b. When the actuator 482 is in itsretracted position, as shown in FIG. 16, the impression member 486 isseated on a lowered section of the ramp 488. In this position, theimpression member 486 is withdrawn from the molten plastic, optionallyin a direction perpendicular the axial direction of movement of theactuator and/or perpendicular to the central axis of the inner core, andthe impression member's profile is contained entirely within the innercore 452. The impression member 486, as shown in FIG. 16, does notinterfere with the material in the molding space 454. Thus, when thevial 412 is sufficiently cool and in solid form, the vial 412 may bewithdrawn from the molding apparatus 400 in an axial direction. Theprocess steps to make the vial 412 substantially resemble those carriedout to make the syringe barrel 212.

While the invention has been described in detail and with reference tospecific examples thereof, it will be apparent to one skilled in the artthat various changes and modifications can be made therein withoutdeparting from the spirit and scope thereof.

What is claimed is:
 1. An injection molding apparatus for forming amedical barrel having a bypass groove within an inner wall of themedical barrel and an undistorted outer wall such that the medicalbarrel can be removed axially from the injection molding apparatus, theinjection molding apparatus comprising: a mold block defining a moldcavity and adapted to receive molten thermoplastic material in the moldcavity, the mold block comprising a unitary piece that is not separableand having a cylindrical opening at one end; an inner core that isadapted to pass through the cylindrical opening and to occupy a portionwithin the mold cavity to define a molding space that is outside of theinner core but within the mold cavity for forming the medical barrel,the inner core comprising a longitudinal space therein; an actuator thatis axially displaceable within the longitudinal space; a sensor beingoperative to monitor at least one parameter within the mold cavity andtransmit a signal representative of the at least one parameter, the atleast one parameter corresponding to a substantial, but not complete,filling of the molding space with molten thermoplastic material, whereinthe sensor is positioned so as not to directly contact the moltenthermoplastic material and thereby not distort the medical barrel; adrive for axially displacing the actuator in response to the signalreceived from the sensor; and an impression member that cooperates withthe actuator to form the bypass groove within the inner wall of themedical barrel when the molding space is substantially, but notcompletely, filled with molten thermoplastic material.
 2. The injectionmolding apparatus of claim 1 wherein the inner core comprises a windowand wherein the actuator comprises: a slot portion in which theimpression member is displaceable; a track that is oriented axiallyalong a portion of the actuator at a first incline; wherein the slotportion comprises a ramp, most of which comprises a second inclinesubstantially parallel to the first incline; and wherein the impressionmember moves perpendicularly to the actuator when the actuator isdisplaced axially, the impression member passing through the window inthe inner core when the actuator is displaced in a first axial directionto form the bypass groove within an inner wall of the molten plastic butwithout distorting an outer wall of the molten plastic.
 3. The injectionmolding apparatus of claim 1 wherein the drive comprises a servo driveand the sensor controls the actuator in a closed-loop configuration, theservo drive causing the actuator to displace in the first axialdirection or in a second axial direction, opposite the first axialdirection.
 4. The injection molding apparatus of claim 3 wherein thesensor is positioned within the mold block to detect the at least oneparameter.
 5. The injection molding apparatus of claim 4 wherein a thinmembrane separates a head portion of the sensor from the moltenthermoplastic material.
 6. The injection molding apparatus of claim 3wherein the servo drive is configured to displace the actuator in thefirst axial direction in response to the signal indicating that themolding space is 95%-99.5% filled with the molten thermoplasticmaterial.
 7. The injection molding apparatus of claim 3 wherein thesensor comprises a pressure sensor.
 8. The injection molding apparatusof claim 7 wherein the servo drive energizes the actuator to move in thefirst axial direction when a pressure of 550-600 bars is detected by thepressure sensor, indicative of the molding space being 95%-99.5% percentfilled with the molten thermoplastic material.
 9. The injection moldingapparatus of claim 2 wherein the drive comprises a pneumatic orhydraulic drive that controls the actuator in an open-loopconfiguration, the pneumatic or hydraulic drive causing the actuator todisplace in the first axial direction or in a second axial direction,opposite the first axial direction.
 10. The injection molding apparatusof claim 9 wherein the pneumatic or hydraulic drive displaces theimpression member in the first axial direction after a predeterminedtime indicative of the molding space being 95%-99.5% filled with themolten thermoplastic material.
 11. The injection molding apparatus ofclaim 10 wherein the predetermined time comprises 0.55 seconds followinga mold closing.
 12. A method for forming a medical barrel having abypass groove within an inner wall of the medical barrel and anundistorted outer wall such that the medical barrel can be removedaxially from the injection molding apparatus, the method comprising:providing a unitary inseparable mold block defining a mold cavity andadapted to receive molten thermoplastic material in the mold cavity andwherein the mold block comprises a cylindrical opening at one end;inserting an inner core that is adapted to pass through the cylindricalopening and to occupy a portion within the mold cavity to define amolding space that is outside of the inner core but within the moldcavity for forming the medical barrel therein and wherein the inner corecomprises a longitudinal space therein; positioning an actuator withinthe longitudinal space and which is axially displaceable therein;monitoring at least one parameter within the mold cavity using a sensorthat transmits a signal representative of the at least one parameter,the at least one parameter corresponding to a substantial, but notcomplete, filling of the molding space with the molten thermoplasticmaterial, wherein the sensor is positioned so as not to directly contactthe molten thermoplastic material and thereby not distort the medicalbarrel; displacing the actuator axially using a drive in response to thesignal received from the sensor; and displacing an impression memberorthogonally from the actuator to form the bypass groove within theinner wall of the medical barrel when the molding space issubstantially, but not completely, filled with the molten thermoplasticmaterial and when the actuator is axially displaced.
 13. The method ofclaim 12 wherein the inner core comprises a window and whereindisplacing the impression member comprises: providing a slot portion inthe actuator that permits the impression member to displace; providing atrack that is oriented axially along a portion of the actuator at afirst incline; providing a ramp within the slot portion and wherein theramp comprises a second incline substantially parallel to the firstincline; wherein displacing the actuator axially causes the impressionmember to move along the first and second inclines, the movement of theimpression member being perpendicular to the actuator's axialdisplacement; and the impression member forming the bypass groove withinthe inner wall of the medical barrel but without distorting the outerwall of the medical barrel by the impression member passing through thewindow in the inner core.
 14. The method of claim 12 wherein the driveis a servo drive and the sensor controls the actuator in a closed-loopconfiguration, the servo drive causing the actuator to displace in afirst axial direction or in a second axial direction, opposite the firstaxial direction.
 15. The method of claim 14 wherein using the servodrive and the sensor comprises: positioning the sensor within the moldblock to detect the at least one parameter; and transmitting, by thesensor, the signal representative of the at least one parameter to theservo drive.
 16. The method of claim 15 wherein positioning the sensorfurther comprises disposing a thin membrane between a head portion ofthe sensor and the molten thermoplastic material.
 17. The method ofclaim 14 wherein displacing the actuator axially comprises the servodrive displacing the actuator in the first axial direction when themolding space is 95%-99.5% filled with the molten thermoplasticmaterial.
 18. The method of claim 15 wherein the sensor is a pressuresensor.
 19. The method of claim 18 wherein displacing the actuator inthe first axial direction occurs when a pressure of 550-600 bars isdetected by the pressure sensor, indicative of the molding space being95%-99.5% percent filled with the molten thermoplastic material.
 20. Themethod of claim 12 wherein the drive is a pneumatic or hydraulic driveto control the actuator in an open-loop configuration, the pneumatic orhydraulic drive causing the actuator to displace in a first axialdirection or in a second axial direction, opposite the first axialdirection.
 21. The method of claim 20 wherein displacing the actuatoraxially comprises the pneumatic or hydraulic drive displacing theactuator in the first axial direction after a predetermined timeindicative of the molding space being 95%-99.5% filled with the moltenthermoplastic material.
 22. The method of claim 21 wherein thepredetermined time comprises 0.55 seconds following a mold closing. 23.The method of claim 12, wherein the drive is a servo drive operativelyconnected to the sensor.
 24. The method of claim 12 further comprisingapplying, in a PECVD process, a trilayer coating set to the inner wallof the medical barrel.